SEND-ASSURE is an audit solution to reduce risks in Regulatory e-Data Submissions
NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis
Nonclinical Study Data Specification (NSDS) for definition of a study before it begins, and ToxVision-as-a-software-Service to review studies after they are completed using the same visualization and analysis tools as in FDA’s NIMS are now available as a software subscription.
For biopharma companies, this collaboration will streamline the flow of high quality CDISC SEND standardized data for regulatory submissions required by the FDA and to serve sponsor R&D needs
PointCross Life Sciences’ SENDBox and SEND-as-a-Service Prepare Pharma Companies to Comply with the FDA’s Upcoming e-Data Submission Mandate
FOSTER CITY, CA, March 11, 2013 PRNewswire